MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-10-25 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.
[90209740]
A follow up report will be filed once the quality investigation is complete. Product was used in patient.
Patient Sequence No: 1, Text Type: N, H10
[90209741]
It was reported by a patient post surgery that the patient reported difficulties. It was further reported difficulties include aesthetic changes due to threads being tied too tightly and vision issues. No further information was available.
Patient Sequence No: 1, Text Type: D, B5
[109811556]
The event reported in this case did not report what nasopore product was used. The product was not available for evaluation. A product malfunction/deficiency was undetermined due to the limited information available. Attempts to get additional information on this event were unsuccessful. Due to the limited information it is not possible to determine if the stryker product contributed to the reported event. The event did not involve a product problem indicating a non conformity or unanticipated hazard. No further action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[109811557]
It was reported by a patient post surgery that the patient reported difficulties. It was further reported that the alleged difficulties include aesthetic changes due to threads being tied too tightly and vision issues. No further information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-01975 |
| MDR Report Key | 6976438 |
| Report Source | OTHER |
| Date Received | 2017-10-25 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-12-12 |
| Date Added to Maude | 2017-10-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_INSTRUMENTSTIRE_PRODUCT |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2017-10-25 |
| Catalog Number | UNK_ICO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-25 |